TUESDAY, Feb. 19, 2019 — Despite adequate levels of prescriber, pharmacist, and patient knowledge regarding transmucosal immediate-release fentanyls (TIRFs), the rates of inappropriate use are high, according to a study published in the Feb. 19 issue of the Journal of the American Medical Association.
Noting that TIRFs are indicated solely for breakthrough cancer pain in opioid-tolerant patients, Jeffrey Eric Rollman, M.P.H., from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues conducted a qualitative analysis of 4,877 pages of U.S. Food and Drug Administration documents, including six annual Risk Evaluation and Mitigation Strategy (REMS) assessment reports (2012 to 2017), to examine whether the REMS program was meeting its goals with respect to TIRFs.
Twelve months after program initiation, the researchers found that 7.9, 11.6, and 2.6 percent of 302 pharmacists, 302 prescribers, and 192 patients incorrectly reported that TIRFs can be prescribed to opioid-nontolerant patients. Between 34.6 and 55.4 percent of patients prescribed TIRFs were opioid-nontolerant in product-specific analyses of claims data at 60 months. Overall, 34.2 percent of prescribers reported prescribing TIRFs for opioid-tolerant patients with chronic, noncancer pain; at 60 months, 18.4 percent of prescribers and 47.7 percent of patients erroneously reported that TIRFs were FDA-approved for such use.
“Despite increasing evidence that the program was not achieving its stated goals, no substantive changes to the program were made by TIRF manufacturers or the FDA to address these shortcomings,” the authors write.
An FDA spokesperson told HealthDay in a statement that the agency “has been actively assessing the recommendations of our advisory committee on the effectiveness of the REMS and necessary changes. The FDA will soon be sharing planned next steps, including intended modifications to the current TIRF REMS, to make sure the program is working to mitigate the risks of these medicines and that they’re prescribed only to opioid-tolerant patients, and that those patients understand the risks and how to use TIRF medicines safely.”
One author disclosed financial ties to the health care industry.
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Posted: February 2019